NSAC's Blog

Understanding FDA’s New FSMA Rule for Produce Farms – Part 2

December 8, 2015

This is the second in a multi-part series analyzing FDA’s recently released rule that sets standards for the growing, harvesting, packing, and holding of produce for human consumption (aka “the Produce Rule”). The first post addressed those farms that may be fully or partially exempt from the Produce Rule. This post provides an overview of what the Produce Rule requires of farms that are covered by the rule.

As we discussed in our earlier post, not all farms are subject to FDA’s new food safety regulations for produce farms. Some farms may be exempt because the volume of produce they are putting in the food supply is “de minimis.” Others may be exempt because they are only growing produce that is not covered by the rule, or produce destined for commercial processing. Moreover, farms selling below a certain sales threshold and primarily into direct markets may be qualified exempt, and therefore eligible for modified requirements.

This post addresses those farms that are not exempt or qualified exempt from the Produce Rule’s requirements, and are therefore subject to the full suite of requirements listed below. It will describe what’s required, the staggered compliance timelines, and discuss language in the rule that speaks to FDA’s approach to compliance, particularly as it relates to the central issues of audits and inspections.

A word of warning – this post is quite long. We decided to put all the basic information about the Produce Rule requirements into a single post so it can be available as a resource guide for farmers and farm advisers. The rule itself is long and incredibly complex and hence there is no way to avoid a lengthy summary. We hope despite its length this “all in one document” approach will prove useful to our readers and supporters. We will also be updating our website soon to reflect this content, and more, in a more user-friendly manner.

What Does the Produce Rule Require?

The Produce Rule is made up of several sets of standards that prescribe certain actions that farmers must take to minimize the risks of microbial contamination on their farms. The major components relate to employee qualifications and training; worker health and hygiene; water used during growing, harvesting, packing, and holding; biological soil amendments of animal origin (manure and compost); wild and domesticated animals; equipment and buildings; and post-harvest activities, like packing and holding.

Before getting into the details, it’s important to note that in some cases the rules explain what standards you must follow, but they don’t necessarily explain how to meet the standard. The “how” may vary from farm to farm, and the rules attempt to provide the flexibility for farms to do what’s appropriate for their operation. More specific information will be coming later from FDA via guidance documents that will help explain certain components of the rules in more detail, as well as through training programs and educational materials.

Some existing training programs and activities may be able to fill in much of the detail needed to understand exactly what to do on your farm. These training programs are likely to be modified — and new training projects are likely to be developed in the coming months and years — to explain the new FSMA requirements in a way that is tailored to a wide variety of types of agricultural operations. Look to your local sustainable agriculture association, or other community-based farm organization, for more information on farmer food safety training, or check in with your University Extension.

The overview below is unlikely to answer all of your questions about what to do on your farm to comply with FSMA. It is intended to provide an overview and guide, to alert you to the key issues and assist you in finding more information specific to your operation.

At the most basic, general level, the rule requires you to: “take appropriate measures to minimize the risk of significant adverse health consequences or death from the use of or exposure to covered produce – including those measures reasonable necessary to prevent introduction of known or reasonably foreseeable hazards, and to provide reasonable assurances that produce is not adulterated.”

More specifically, the rule sets forth standards under the following categories:

There is a separate set of standards within the Produce Rule for the growing, harvesting, packing, and holding of sprouts, which we will not cover here, but can be accessed via the Federal Register.

The Produce Rule also sets standards that relate to analytical methods, variances, and compliance and enforcement. Read on for more details on each category.

1. Personnel Qualifications and Training

This section addresses qualification and training requirements for farm personnel who handle covered produce and/or food contact surfaces. Both supervisors and personnel must receive “adequate training as appropriate to [their] duties.” Such training must occur upon hiring, and periodically afterward, but at least once annually.

Moreover, all personnel and supervisors must have “a combination of education, training, and experience necessary to perform the person’s assigned duties.” This means that not all farm employees must be trained in all aspects of food safety; but some degree of training is required based on the nature of their position on the farm.

At a minimum, farm employees that are involved in growing, harvesting, packing, or holding covered produce must be trained in:

Principles of food hygiene and food safety;

The importance of health and personal hygiene; and

Other applicable standards.

Harvesters must also receive training to:

Recognize produce that must be not harvested;

Inspecting and cleaning harvest containers/equipment to avoid contamination; and

Correct problems with harvest containers/equipment (or report those problems to the supervisor as appropriate to their job responsibilities).

At least one “supervisor or responsible party” for your farm must have successfully completed food safety training that is “at least equivalent” to that received under “standardized curriculum recognized as adequate by FDA.”

Equivalent vs Standardized Curriculum

FDA is currently in the process of working with the Produce Safety Alliance (PSA) curriculum to recognize it as an adequate standardized curriculum once it is completed. However, FDA has made it clear that you are not required to take the PSA training program, as long as you take a training equivalent to the PSA in terms of outcomes.

Specifically, the preamble to the rule acknowledges that farmers or industry can develop training materials or programs uniquely suited to their commodities or operations, as long as they cover the topics specified in the rule. Moreover, “existing programs can modify their training program structures and curriculum to ensure consistency with and provide at least equivalent level of instruction to the standardized curriculum without necessarily adopting the PSA (or Sprout Safety Alliance) training structures or materials.”

As with other alternatives, an alternative training does not have to be pre-approved by FDA before you take it, but you must retain records that document the training taken – including the date, topics covered, and person(s) trained. You are not required to have a certificate from the training, but a certificate could serve as part of your training records.

FDA has indicated that it will be entering into cooperative agreements to focus on tailored education and training for local foods producers and Tribal producers. Once finalized, these trainings will also be considered “FDA-recognized.” It is quite likely that those trainings, and others, will become available in the coming months and years. For smaller farms that have three or four years before they must be in compliance, you may wish to wait until more information about training options becomes available before you take a “FSMA training.” NSAC will continue to provide information on training issues as it becomes available.

2. Health and Hygiene

This section includes required measures farms must take to protect against contamination from sick employees and from visitors. These include, for example, excluding a sick person from working with covered produce if the person has (or appears to have) an applicable health condition (such as a communicable illness, infection, vomiting, etc), and instructing personnel to notify their supervisor or other responsible party if they have – or there is a reasonable probability they have – such a condition.

Visitor contamination prevention include making visitors aware of policies and procedures in place to protect covered product and food contact surfaces from contamination, and taking all steps reasonably necessary to ensure that visitors comply with such policies and procedures. You must also make toilet and hand-washing facilities accessible to visitors.

It also addresses specific hygienic practices for personnel, which include: personal cleanliness; avoiding contact with animals other than working animals, and taking appropriate steps to minimize the likelihood of contaminating covered produce when in direct contact with working animals; washing hands; removing or covering hand jewelry that can’t be adequately cleaned; and not eating, chewing gum, or using tobacco products in areas used for covered activities.

In general, “all agricultural water must be safe and of adequate sanitary quality for its intended use.”

FDA defines “agricultural water” as “water used in covered activities on covered produce where water is intended to or likely to contact covered produce or food contact surfaces, including water used in growing activities (including irrigation water applied using direct water application methods, water used for preparing crop sprays, and water used for growing sprouts) and in harvesting, packing, and holding activities (including wash water, or water used for cooling or preventing dehydration).

Direct water application method means “using agricultural water in a manner whereby the water is intended to, or is likely to, contact covered produce or food contact surfaces during use of the water.” So this would include overhead irrigation of tomatoes, but probably not drip irrigation of tomatoes. However, it would include buried drip irrigation of carrots or other root crops.

Water that meets the definition of “agricultural water” is then subject to requirements regarding inspection and regular maintenance; compliance with the proper microbial water quality criteria; and testing frequencies.

This means that if water is used in a way that does not meet the definition of agricultural water — for example, is not intended to or is unlikely to contact covered produce like the drip irrigation of tree crops — then the requirements of this section do not apply to that water.

Inspection and Regular Maintenance

At the beginning of the growing season, or at least once annually, you must inspect your entire agricultural water system, which includes your water sources, distribution systems, facilities, and equipment, to identify any conditions that are reasonably likely to introduce know or reasonably foreseeable hazards into or onto covered produce or food contact surfaces.

This should include consideration of:

The nature of each agricultural water source;

The extent of your control over it;

The degree of protection each source has;

Adjacent and nearby land use that may impact your water quality; and

The likelihood of introduction of known or reasonably foreseeable hazards by another upstream water user.

You must adequately maintain: all water sources, to the extent they are under your control (e.g. by regularly inspecting, removing debris, trash etc); your water distribution system to the extent it is under your control; and your water system to reduce the potential for covered produce to contact pooled water.

Microbial Water Quality Criteria

The rule establishes two different microbial water quality standards based on the water’s intended use.

For water used to irrigate sprouts; to directly apply to covered produce during harvest or post-harvest activities; for food contact surfaces, or in hand-washing during harvest/post-harvest handling, the standard is no detectable generic E. coli per 100mL. The rule prohibits the use of untreated surface water for any of these harvest and post-harvest purposes.

For water used during growing activities – when used in a manner that is intended or likely to contact the covered produce – the standard is:

A geometric mean (GM) of your agricultural water samples of 126 or less colony forming units (CFU) of generic E. coli per 100 mL of water; and

A statistical threshold value (STV) of your agricultural water samples of 410 or less CFU of generic E. coli per 100 mL of water.

As FDA explains it: “the GM measures what is called the central tendency, which is essentially the average amount of generic E. coli in a water source. The STV reflects the amount of variation in the E. coli levels, which can be caused by events such as a heavy rainfall. It measures expected deviations from the average for a water source. Collectively, both pieces of information provide a more complete description of your water quality than either one alone.”

If, based on test results, you satisfy the above water quality criteria, then you may use your water as planned. If, however, your water quality exceeds the threshold, then you can still use the water, provided you either:

Stop using the water source until you re-inspect your water distribution system to see if you can determine what’s wrong, rectify it, and then verify that your action was effective to bring the water back under the threshold;

Treat the water; or

Apply a time interval (in days) between when you last water and when you harvest that is based on a calculation that measures the die-off of microbes due to natural factors like exposure to wind or sun (NOTE: this is only an option for water used during growing, not for water used in harvest or post-harvest activities).

If you are treating your water, there are requirements that relate to the effectiveness of treatment, the delivery of treatment, and monitoring the effectiveness of the treatment.

Microbial Die-Off

As provided in option #3 above, if you are using water to irrigate in a way that directly contacts the harvestable portion of the crop, and your water quality exceeds the above STV and GM thresholds, you can still use that water as long as you wait enough time between irrigation and harvest to account for the natural reduction in generic E. coli (the “microbial die-off”) that would bring you within the threshold.

FDA has provided a die-off rate of 0.5 log reduction per day that you can apply to determine the number of days you must wait between irrigation and harvest if your water exceeds the microbial standard. This rate means that every day after you irrigate, you can assume a roughly 67% reduction in generic E. coli on the surface of the crop due to natural causes like sunlight, moisture, temperature, pH, etc. You therefore wait enough to days to account for the estimated reduction in generic E. coli needed to bring you below the standard. You do not have to test to verify that the die-off rate is accurate, as long as you keep records of your calculation and length of time you waited between irrigation and harvest.

However, if it would take more than 4 days for the microbial die-off to bring you below the microbial water quality standard, then you cannot use that water source to irrigate covered produce, unless you switch to an irrigation method where the water is unlikely to contact the harvestable portion of the produce, or you treat the water.

If this confuses you, you aren’t alone. This is a complicated concept, and FDA recognizes that they will need to provide guidance and education to help farmers calculate the appropriate number of days that they need to wait between the end of irrigation and harvest, including the development of an online tool to help farmers calculate the GM, STV, and die-off values.

Testing

You do not have to test water that is treated, or municipal water that meets the microbial water quality standard, as long as you have results or certificates of compliance that demonstrate that the water meets that standard.

Initially, you must conduct a survey of the water source to develop a “baseline water quality profile.” This must be based on at least 20 samples, collected as close as is practicable to harvest over two to four years. The initial survey findings are used to calculate the GM and STV, and determine if the water meets the required microbial quality criteria or if you must take some action – like changing the irrigation method so it isn’t direct, switching to a different water source, or applying the die-off rate – in order to use the water.

Annually, you must take at least five samples to update the GM and STV calculations.

Then, each year, use the current year’s five samples and the most recent 15 samples to create a rolling 20-sample dataset to recalculate the water quality profile and confirm that the current water use is still appropriate, or whether changes need to be made (e.g. by adjusting the number of days between application and harvest to account for microbial die-off relevant to the current profile). Such changes would have to be made as soon as practicable, but at least by the next year.

Groundwater

Initially, you must develop a baseline water quality profile based on at least 4 samples.

Annually, take at least one sample, as close as practicable to harvest.

Then, each year, update the baseline profile by combining the annual testing results with the most recent initial or annual survey data to making a rolling data set of at least four samples.

The same reasoning and corrective actions described above in the surface water standard (switching source, irrigation method, or applying the die-off rate) apply.

However, if untreated groundwater must meet the “no detectable generic E. coli” standard (e.g. is being used in harvest or post-harvest activities), then if any single annual sample fails to meet the threshold, you must resume testing at least four times per yer as per the initial survey.

The baseline and annual testing must be done for each distinct water source. That means if you draw from several rivers, then you have to apply to full testing regime to each of those rivers. If you draw from several points along the same river, however, you do not need to test at each point, as long as the samples you draw from one point are representative of the water at the other points (e.g. there is nothing in between the points that would alter the water quality).

The rule requires you to either use the testing method of analysis published the EPA known as Method 1603 or “Modified mTEC,” or any other scientifically valid method that is at least equivalent to this method of analysis in accuracy, precision, and sensitivity.

Alternatives

There are provisions in the rule that allow farmers to use alternative standards in place of: the microbial water quality standard for untreated irrigation water; the microbial die-off rate; and the testing frequency for untreated surface water. However, you must have “adequate scientific data or information” to support a conclusion that your alternative provides “the same level of public health protection” as FDA’s standards.

According to the FDA, the farmer can develop the scientific data relied upon to support the alternative, or it can come from the scientific literature, or be available through a third party. You have to establish and retain documentation that justifies the alternative, but you do not have to notify FDA or receive approval prior to using the alternative.

The rule does not allow for alternatives to the testing frequency for groundwater, or alternative microbial standards for water used during harvest or post-harvest handling.

While this language appears to be broad, it is unclear how farmers will actually be able to take advantage of this option, especially in the short term. In the preamble to the rule, FDA states it “anticipate[s] that the necessary scientific support for an alternative could be developed with broad efforts across the produce community, involving academic, extension services, industry associations, and government agencies.” FDA has also said that they will issue guidance relating to the water standard to provide more information to farmers on how to follow it.

That is why it is important to keep in mind that the compliance timelines for the water standard are longer than the general compliance timelines. All farms already have two, three, or four years to come into compliance with the rules based on their status as a small or very small business (which is based on sales), and all farms have two extra years to come into compliance with the water standard. Because the 20-sample baseline can be based on up to four years’ worth of data, there is still time in the next few years for FDA and industry outreach and education to provide more information on how to comply, still time to collect those initial samples, and still time for research to continue and results be disseminated that could lead to possible alternative options.

The rules also contain general requirements for measures to take for water used during harvest, packing, and holding activities. These include, for example, managing the water by establishing and following water-change schedules for recirculated water; visually monitoring the water quality; and maintaining and monitoring water temperature.

And, you must keep records that document: the findings of your water source inspection; test results; any data you rely upon to support alternatives; results of water treatment monitoring; documentation of the use of the microbial die-off rate; results/certificates of compliance for municipal water, etc.

4. Biological Soil Amendments of Animal Origin

This section sets standards for handling, transporting, storing, treating, and applying biological soil amendments of animal origin (BSAs). This applies to soil amendments that consist partially or entirely of materials of animal origin, so that includes but is not limited to raw and composted manure.

Agricultural teas — defined as “a water extract of biological materials produced to transfer microbial biomass, fine particulate organic matter, and soluble chemical components into an aqueous phase” — are soil amendments, and are BSAs and covered by this part when they contain animal manure or non-manure animal byproducts.

The rule prohibits the use of human waste as a biological soil amendment, unless in the form of sewage sludge biosolids. (The use of sewage sludge, it should be noted, is prohibited under the USDA National Organic Program).

Standards for Treated BSAs

Treated soil amendments must be “processed to completion to adequately reduced microorganisms of public health significance.” In the case of agricultural teas: the biological materials must be processed to adequately reduce microorganisms of public health significance, untreated surface water cannot be used to make the tea, and the water must meet the requirements above for water used in harvest/post-harvest activities (no detectable generic E. coli per 100mL).

Static composting that maintains aerobic (i.e., oxygenated) conditions at a minimum of 131 °F (55 °C) for 3 consecutive days and is followed by adequate curing; and

Turned composting that maintains aerobic conditions at a minimum of 131 °F (55 °C) for 15 days (which do not have to be consecutive), with a minimum of five turnings, and is followed by adequate curing.

If you are using soil amendments containing animal byproducts (whether manure or fish emulsion, for example) and it does not meet the above criteria for treatment, then it is considered untreated. It is also untreated if it has been recombined with untreated biological soil amendments, or there is reason to believe that a treated amendment has become contaminated with untreated waste.

Therefore, there are also requirements regarding the handling, storage, and transport of BSAs to minimize the risks of cross contamination between treated and untreated products, and to avoid untreated materials from becoming a potential source of contamination.

Application Intervals

Application intervals vary based on the type of BSA (treated or untreated) and also the method of application.

If composted manure is applied in manner that minimizes the potential for contact with covered produce during or after application, then you do not have to wait any specified number of days between application and harvest. The same is true for manure that has been treated to the first set of standards, in which case the treated amendment can be applied without any restrictions.

If untreated manure is applied in a manner that does not contact covered product during or after application, then no restrictions are placed on the time between which it can be applied and harvest.

FDA is following through with the proposal from the second draft of the Produce Rule to defer finalizing the application interval for raw manure applied in a manner that does not contact produce during application, and minimizes the potential for contact after application (i.e. there is still some potential that contact could occur, unlike the case above where no contact will occur).

As you may recall, in light of public comments, concerns about conflicting with the National Organic Program (NOP), and the lack of a robust scientific justification for the originally proposed 9-month application interval, FDA has decided to pursue the necessary research and risk assessment to justify an appropriate application interval, and will re-propose that interval at a later date, likely sometime in the next 5-10 years.

Meanwhile, certified organic farmers are expected to continue following the NOP standards regarding the application of raw manure (90-120 days, depending on the application method), and other farmers may also wish to adhere to the same or a similar standard as a prudent interim measure.

Records

For any biological soil amendment of animal origin that you use on your farm, you must maintain records that document the validity of the treatment process. For manure purchased from third parties, you have to document at least annually that (1) the treatment process used is scientifically valid and carried out with appropriate process monitoring and (2) has been handled, conveyed, and stored in a manner and location to minimize the risk of contamination by untreated or in process waste.

If you are making the compost yourself, you must be able to document that you are using a valid controlled biological process known to meet the relevant microbial standard. If you are using the static or turned composting methods detailed above, then you do not have to test that the process has resulted in an amendment that meets the standard, but you do need to document that you’re following process controls (e.g. with records of time, temperature, turning (as appropriate), and curing).

5. Domesticated and Wild Animals

This section of the rule sets out standards to minimize the food safety risks associated with wild or domesticated animals. The following requirements apply to growing, harvesting, packing, and holding when done in an outdoor area or partially enclosed setting, and when – under the circumstances – there is a reasonable probability that animals will contaminate covered produce. They do not apply to covered activities that take place in a fully enclosed building, or to fish used in aquaculture.

If there is a reasonable probability that grazing animals, working animals, or wild or domesticated animal intrusion will contaminate produce, then you must:

Assess the relevant areas used for covered activities for evidence of potential contamination as needed during the growing season. This determination is expected to be site-specific, and based on your covered produce, your practices/conditions, and your observations and experiences; and

If significant evidence of potential contamination is found (such as by observing animals, poop, crop destruction in/around covered produce), then you must evaluate whether the covered produce can be harvested (e.g. by doing a visual assessment of the growing area and the produce to be harvested, and assessing whether there is visible contamination) and take measures reasonably necessary during growing to help later during harvest in identifying produce that is reasonably likely to have been contaminated and not harvest such produce.

If domesticated animals are located in or around fully enclosed buildings, then you must take precautions to prevent contamination by (1) excluding domesticated animals from fully enclosed buildings where covered produce, food contact surfaces, or food packing material is exposed or (2) by separating domesticated animals in a fully enclosed building by time, location, or partition. Guide or guard dogs can be in some areas if they are unlikely to result in contamination.

The rule also contains important language intended to convey to farmers, auditors, and regulators that nothing in the rule requires covered farms to take measures to exclude animals from outdoor growing areas, or to destroy animal habitat or otherwise clear farm borders around outdoor growing areas or drainages.

Although the regulatory text itself does not reference co-management, the preamble to the rule reiterates FDA’s commitment to supporting and encouraging the co-management of food safety, conservation, and environmental protection; that they encourage the application of such practices that both enhance food safety and are consistent with sustainable conservation; and that they believe it is important to take into account the environmental standards and policies of other relevant agencies in the context of food safety.

It will be important to monitor the implementation of the provisions related to animals and wildlife to ensure that FDA’s intentions regarding co-management are clear, and that farmers are not being discouraged from using practices that benefit both conservation and food safety.

Handling harvested produce in a way that prevents against contamination with known or reasonably foreseeable hazards; and

Using packaging adequate for its intended use (whether cleanable or single-use) and unlikely to support the growth or transfer of bacteria.

7. Equipment, Tools, and Buildings

The rule contains standards specific to tools or equipment intended to or likely to contact covered produce, and buildings (whether partially or fully enclosed, and including storage sheds). In general, it requires and equipment be:

Designed, installed, and stored to allow for adequate cleaning and maintenance; and

Inspected, maintained, and cleaned when appropriate and as frequent as necessary to protect against contamination

Similarly, building must be suitable in size, construction, and design to facilitate maintenance and sanitary operations; must provide sufficient space for storage of materials and equipment; permit proper precautions to be taken regarding the potential for contamination (e.g. separation of operations that introduce the potential for contamination by location, time, partition, etc).

An adequate description of the relevant covered produce (i.e. commodity name and lot number or other identifier);

The location of the growing or post-harvest area (e.g. specific field or packing shed), and;

The date and time of the activity documented.

Records should be created at the time an activity is performed or observed; be accurate and legible; and be dated and signed or initialed by the person who performed the documented activity.

Certain records must also be reviewed, dated, and signed within a reasonable time after the records are made by a supervisor or responsible party. These include: records pertaining to a farm’s qualified exempt status; training; water tests results; water treatment monitoring; application of a time interval between irrigation and harvest based on the 0.5 log reduction; composting process controls for compost you make on your farm; and cleaning and sanitizing tools and equipment. If the supervisor or responsible party (e.g. the owner-operator) creates the record, then it does not require the second step of being reviewed.

Records can be based on existing records, be written or electronic, be either the original or photo/scanned copies, and be stored offsite as long as they can be retrieved and provide within 24 hours of request for official review. They must be retained for at least two years past the date the record was created.

As we noted in our last post, records that a farm relies on to justify a qualified exemption must be retained as long as necessary to justify the calculation based on a three-year average, so three years would be appropriate in those instances rather than two years.

Alternatives/Variances

As discussed above, the rule provides some options for alternatives to certain parts of the water standard. The rule otherwise does not include specific allowances for alternatives, although in many sections the standards are written in a way to allow for the use of different processes or practices (e.g. you can take any training “at least equivalent” to the FDA-recognized standardized curricula; you can use any “scientifically valid” controlled physical, chemical, or biological process for treating manure as long as it satisfies the specified standard).

The rule also provides a process whereby any state, federally-recognized tribe, or foreign country exporting food into the U.S. can submit a petition requesting a variance from one or more requirements of the rule if they can justify that:

The variance is necessary in light of local growing conditions and

The procedures, practices, and processes are reasonably likely to provide the same level of public health protection as FDA’s requirements.

It is unclear whether and to what extent this option will be pursued by states, tribes, or other other governments, and if so, if they will seek complete variances or just variances to certain sections of the rule (e.g. the water standard).

Interestingly, if granted, FDA could specify that a variance granted could also apply to other farmers in specific locations who are similarly situated to those identified in the position. If they were to do so, then they would publish a notice on their website announcing such a decision.

So, What’s Not Required?

After reading the above, you may find it hard to believe that there are certain practices or processes that the rule does not require. However, FDA has specifically stated that the following activities are not required.

1. Registration

In the initial proposed rule, FDA considered the idea of establishing a farm registration requirement for all farms covered by the rule. In the final rule, FDA did not finalize such a requirement. However, FDA notes that they still “believe an inventory of farms would enable us to better provide outreach and TA to covered farms and allocate inspection resources” and so they “intend to pursue other avenues for identifying farms.”

While FDA does not provide significant detail as to what this means, they do note that they have entered into a cooperative agreement with the National Association of State Departments of Agriculture (NASDA) and that through that agreement they “will explore whether and how an inventory of farms in the US may be developed and may enhance these efforts.”

It is important to note that farm mixed-type facilities (those farms that are also subject to the Preventive Controls Rule because of the value-added processing they do to their produce) do have to register with FDA as facilities. See our earlier posts for more on the issue of farms that must register.

2. Food Safety Plans

In the original proposed rule, FDA also raised the possibility of requiring all covered farms to develop, implement, and maintain food safety plans. Ultimately FDA decided not to require them because they would be requiring more than the minimum standard that FSMA requires. However, FDA does strongly recommend them, and will provide more information about operational assessments and food safety plans in guidance.

3. Audits

As we have noted throughout this process, FSMA contains important statutory language – championed by Senator Michael Bennett (D-CO) — that prohibits FDA from requiring farms or food businesses covered by the Preventive Controls or Produce Rule to hire a third party to identify, implement, or certify practices required by the rule.

The Produce Rule does not contain any explicit requirement for farms to undergo third party audits or certification — though some farms may already be doing so based on buyer demand. However, as discussed below within the context of inspections, FDA has also made it clear that they will look to audits as part of their compliance strategy. And as we noted in our analysis of the Preventive Controls Rule, the supplier verification requirements that receiving facilities must put in place may have the result of creating a de facto requirement that farms to undergo audits in order to continuing supplying those facilities with produce.

NSAC strongly opposes this outcome, which runs counter to the letter and the spirit of FSMA, and continues to advocate that FDA use caution in implementing this provision so as to avoid violating the statutory mandate.

It is important to note that under the supplier program, an audit is only one of several verification measures that a buyer could use to ensure their suppliers are adhering to any necessary food safety requirements. And, critically, buyers are not required to start ensuring their suppliers are in compliance with the Produce Rule requirements until the farm’s general compliance timeline has begun. This is intended to ensure that buyers do not pressure farms into coming into compliance with portions of the rule sooner than they would have to under FDA’s staggered compliance timelines.

Compliance Dates

We have discussed compliance dates above as they relate to specific parts of the rule, but to recap: in general, the following compliance dates apply:

Farms grossing no more than $250,000 in produce sales annually (based on a rolling three-year average) are considered very small businesses, and the general compliance date for very small businesses is four years from the effective date of the rule (so four years from January 26, 2016, i.e., January 2020).

Farms grossing no more than $500,000 in produce sales annually (based on a rolling three-year average) are considered small businesses, and the general compliance date for small businesses is three years from the effective date of the rule (so, three years from January 26, 2016, i.e., January 2019).

Farms that gross more than $500,000 annually in produce sales: two years to come into compliance from the effective date of the rule (so, two years from January 26, 2016, i.e., January 2018).

And then for each category, add two extra years to come into compliance with the agriculture water standard components related to the microbial water quality standard and testing frequencies.

Inspections

How exactly FDA will verify compliance once these timelines set in is still not entirely clear. The Produce Rule preamble does provide some hints as to FDA’s plans, but in general these statements raise more questions than answers. Here are some quotes from the preamble related to compliance activities, including both inspections and audits:

FDA’s inspection resources will be targeted based on risk. In addition to conducting its own inspections, FDA also plans to rely heavily on States to conduct a large proportion of the routine inspections on farms. Thus, inspection will play an important role in the overall compliance effort.

FDA intends to develop a work plan regarding routine farm inspections. FDA is exploring the possibility of pre-announcing at least some farm inspections; however, there will likely be instances where a farm will not receive prior notice regarding an inspection.

FDA anticipates that significant incentives and accountability for compliance with this rule will come through third-party audits and supply chain management initiated by produce farms, their customers, or other private entities. We believe it is important to have significant oversight of farms to ensure compliance with the rule. Thus, as a complement to State and FDA inspections of farms, we intend to leverage the conduct of reliable third-party farm audits by USDA and others, as well as compliance with marketing agreements, with a goal of annual verification of farms that must comply with the rule.

Adequately rigorous and reliable private audits can be an important additional tool for fostering food safety and ultimately compliance with this rule [and] we intend to pursue the goal of making third-party audits an important part of our compliance strategy by building on current private audit activity and by working with the produce industry and other government and private partners to improve the rigor and reliability of private audits. We believe that strengthening both the quality and credibility of private audits will help improve food safety, especially if conducted on the basis of the standards in this rule, but it can also be the basis for streamlining current audit practices and making them more efficient. Potentially, a single annual audit that is recognized to be a rigorous and reliable means of verifying compliance with this rule could substitute for multiple audits conducted under disparate standards with less well-established credibility. We seek public-private collaboration to achieve this goal.

As we’ve noted before, NSAC has urged caution in relying on third party audits as indicators of compliance, and this language in the Produce Rule only adds to the concerns that third party audits could become a default regulatory requirement for all farms and small food businesses under FSMA.

We find many of FDA’s statements above quite concerning without a clear and inclusive process through which FDA will determine which audits will be considered “adequately rigorous and reliable” for compliance activities.

The same is true for FDA’s plans regarding annual verification of farms via either audits or inspections. Setting an annual routine inspection standard appears to strongly contradict the notion that inspections are risk-based, and we urge FDA to provide the public with an opportunity to weigh in on any inspection “work plans” prior to finalization.

Given the significant costs and burdens associated with third party audits, and the rise in innovative and less burdensome certification schemes like GroupGAP, FDA’s compliance strategies should not only be transparent, but they also should be comprehensive and hold second party audits and other compliance indicators – like industry education and training – to the same estimation as third party audits.

Additional Information and Resources

Stay tuned for more analysis on the economic and environmental impacts of the rule, as well as additional information on implementation, training, and appropriations.

FDA will be following up on many issues in the final rule by developing guidance documents, which provide more explanation for the regulated industry (and regulators) to use in determining whether and how the final rules apply to a specific situation.

FDA is accepting questions and suggestions as they begin to develop these documents. You can submit questions or recommendations to FDA here to assist them in identifying issues that will require further explanation, or to request a specific response to your question or situation.

FDA has issued a flow chart specific to understanding coverage under the Produce Rule. In the near future, NSAC will be updating our website and “Am I Affected” flowchart to reflect both the Produce and Preventive Controls final rules, designed to help farmers, small food businesses – and the organizations that work with them – understand whether the FSMA rules apply to them and if so, what requirements apply.

You can view the final regulations and the discussion of comments received on the proposed rule via the Federal Register or FDA’s Produce Rule webpage.

You may also be interested in our analysis of the Preventive Controls Rule. Remember that some produce and non-produce farms that also do value-added processing may also be subject to the Preventive Controls Rule.